POS0528 PATIENT EXPERIENCES WITH CHRONIC REFRACTORY GOUT AND ITS IMPACT ON HEALTH-RELATED QUALITY OF LIFE
Authors: A. Oladapo, V. Strand, N. Kragh, N. Johnson, C. Yousefian, D. Brooks, H. Sharp, C. Kim, M. Pillinger
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Gout is a common inflammatory rheumatic disease, with elevated uric acid leading to deposition of monosodium urate crystals within joints <sup>[1]</sup>. Chronic refractory gout (CRG), also known as refractory or uncontrolled gout, is associated with unexpected disease flares characterized by severe and debilitating pain. Long-term symptoms include painful inflammatory arthritis, impaired physical function, and health-related quality of life (HRQoL), and tophi-related joint destruction <sup>[1]</sup>. <h3>Objectives</h3> This study aimed to 1) develop and refine a conceptual model of patient-identified CRG symptoms and their impact on HRQoL; and 2) confirm that the 36-item Short Form Health Survey V2.0 (SF-36) and Health Assessment Questionnaire-Disability Index (HAQ-DI) are relevant to patients with CRG by mapping items to the CRG conceptual model. <h3>Methods</h3> A targeted literature review of the 10 years prior to August 2021 was conducted to assess the symptoms and impacts of CRG, alongside the use of SF-36 and HAQ-DI in previous clinical trials. The review results contributed to an initial conceptual model of signs, symptoms and impacts of CRG. This model was then refined using concept elicitation interviews (CEI) conducted with patients who have clinically confirmed CRG (≥3 gout flares within 18 months of screening; or presence of ≥1 tophus; or current diagnosis of gouty arthritis [defined as joint damage due to gout]). Interviews contained open-ended questions and patients were asked about duration, frequency, and severity for each concept; bothersome impacts were rated on a scale of 0–10. The refined model was then assessed against SF-36 and HAQ-DI to determine their suitability for evaluating disease burden in patients with CRG. <h3>Results</h3> Findings from the literature review identified the following commonly referenced symptoms, signs and impacts of gout that served as the basis of the draft conceptual model: bodily pain, joint swelling/inflammation, tophi, joint pain, joint tenderness, anxiety, depression, sleep effects, and work effects. Impacts were organized into five domains: activities of daily living (e.g., difficulty dressing), emotional (e.g., anxiety), physical (e.g., decreased mobility), social (e.g., stigma), and work/school (e.g., productivity). Twenty patients were interviewed. Most were male (70%) and non-Hispanic white (55%), with a mean (standard deviation) age of 55.9 (±12.1) years. Most patients (60%) reported having multiple (&gt;3) and/or severe gout flares within the past 6 months, and most commonly 1–3 tophi (45%). The most frequently reported signs and symptoms included bodily pain, joint swelling, and tenderness (90% each). Others included joint pain (80%), joint stiffness (70%), and tophi (70%). Joint pain was rated as the most bothersome symptom (mean = 9.1). The most frequently reported impacts were difficulty climbing one or several flights of stairs (100% each), followed by completing chores, running errands and shopping, climbing five steps, putting on shoes, walking outdoors on flat ground, and emotional impacts (95% each). Impacts reported varied depending on the affected joints. The most bothersome impact reported was walking outdoors (mean = 9.6). All concepts discussed in the interviews were reviewed to determine whether they reflected the items included in SF-36 and HAQ-DI. Each assessed item from the two instruments was reported as relevant by at least 25% of participants and thus mapped consistently to concepts elicited by participants. Results of the CEI were used to revise the conceptual model (Figure 1). <h3>Conclusion</h3> Symptoms and associated impacts of CRG on HRQoL are multi-faceted, revealing a burden of disease that affects most aspects of a patient's life (Figure 1). Based on the interview data, all assessed items of SF-36 and HAQ-DI mapped directly to the domains and concepts included in the conceptual model, providing evidence that both questionnaires are suitable for assessing the burden of CRG. <h3>Reference</h3> [1]Tatlock S, et al. <i>Patient</i> 2017;<b>10</b>(1):65–79. <h3>Acknowledgements</h3> Medical writing and editorial support, funded by Swedish Orphan Biovitrum AB, was provided by Catherine Hoare, PhD, Bioscript Group, Macclesfield, UK. <h3>Disclosure of Interests</h3> Abiola Oladapo Employee of: Sobi, Vibeke Strand Consultant of: AbbVie, Alpine Immune Sciences, Alumis, Amgen Corporation, Aria, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celltrion, Endo, Equillium, Ermium, Genentech/ Roche, Gilead, GSK, Horizon, Inmedix, Kiniksa, Lilly, Merck, MiMedx, Novartis, Omeros, Pfizer, Priovant, Regeneron, R-Pharm, Samsung, Sandoz, Sanofi, Scipher, Setpoint, Sorrento, Spherix, Tonix, Nana Kragh Employee of: Sobi, Nathan Johnson Consultant of: Endpoint Outcomes (a Lumanity company) was hired to conduct the qualitative study described in the abstract, Charis Yousefian Consultant of: Endpoint Outcomes (a Lumanity company) was hired to conduct the qualitative study described in the abstract, Dani Brooks Consultant of: Endpoint Outcomes (a Lumanity company) was hired to conduct the qualitative study described in the abstract, Harlow Sharp Consultant of: Endpoint Outcomes (a Lumanity company) was hired to conduct the qualitative study described in the abstract, Christine Kim Consultant of: Endpoint Outcomes (a Lumanity company) was hired to conduct the qualitative study described in the abstract, Michael Pillinger Consultant of: Horizon Therapeutics, Fortress Biotech, Grant/research support from: Investigator-initiated grants, with funds going to my institution (NYU Grossman School of Medicine) from Horizon Therapeutics, Hikma Pharmaceuticals.